Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde

Acronym

Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde

Scientific Title

Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde

Scientific Title:Acronym

Relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde

Region

Japan

Condition

Condition

A healthy adult

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

YES

Objectives

Narrative objectives1

To elucidate relationship between ALDH2 and ADH1B phenotypes and circadian variation of endogenous ethanol and acetaldehyde

Basic objectives2

Others

Basic objectives -Others

None

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

Breath endogenous alcohol and acetaldehyde concentrations

Key secondary outcomes

ADH1B and ALDH2 genotypes

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention is straight for 2 days. A subject is sampled his/her breath 4 times for the 2 days; on rising (5:00~7:00), before lunch (11:00~13:00), before dinner (17:00~19:00) and before retiring (23:00~25:00). Sampling is taken after at least 3 h of fasting and 1 h of washing mouth. A subject abstains from alcohol during intervention.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

･20<= years-old
･Male and Female
･A person who is provided sufficient explanations about this study and consented to it in writing by his/her own free will

Key exclusion criteria

･an inappropriate person for this study
･a person who has any airway diseases or liver diseases